Amlodipine + Valsartan + Hydrochlorothiazide
Indications
Amlodipine + Valsartan + Hydrochlorothiazide is used for:
Treatment of hypertension. Indicated in patients whose blood pressure is not adequately controlled on dual therapy or as replacement therapy in patients already receiving amlodipine, valsartan and hydrochlorothiazide at the same dose levels from separate tablets.
Treatment should not be initiated with these fixed-dose combinations
Reduction in BP helps lower the risk of fatal and nonfatal cardiovascular events, mainly stroke and MI
Adult Dose
By mouth, one tablet once-daily. Titrate up to a max. dose of 10/320/25 mg (see Note below)
NOTE:
The triple fixed-dose combination is ONLY indicated as substitution therapy in patients whose BP is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual–component formulation with a single-component formulation, all components at the same dose level.
When the BP is not controlled on one of the 3 possible dual combination therapies, then any third monotherapy must be first added as an individual therapy until dose titration is complete and BP control established before the triple fixed-dose combination may be introduced.
Direct dose-titration within the triple fixed-dose combination product range is not recommended. If a patient’s BP is uncontrolled at one of the lower dosage of the combination, dose titration must be carried out with the separately administered components
Child Dose
Not recommended for use in patients aged below 18 years due to a lack of safety and efficacy data
Renal Dose
Severe renal impairment (GFR<30 ml/min/1.73 m²) and patients undergoing dialysis: Contraindicated
Administration
For oral use.
May be taken once daily, with or without food.
Advise patient to swallow the tablets with a sufficient amount of fluid (e.g. one glass of water); daily dose should be taken at about the same time each day
Contra Indications
Hypersensitivity to amlodipine, valsartan, hydrochlorothiazide or to any of the excipients.
Patients with anuria and patients who are hypersensitive to other sulfonamide-derived drugs, because of the hydrochlorothiazide component.
Severe hepatic impairment; biliary cirrhosis and cholestasis
Severe renal impairment (GFR<30 ml/min/1.73 m²) and patients undergoing dialysis
Concomitant use with aliskiren in patients with diabetes;
Pregnancy, breastfeeding
Precautions
Avoid use in women planning to become pregnant and while breast-feeding;
Risk of hypotension in sodium- and/or volume-depleted patients (Correct volume depletion prior to initiation);
Increased risk of angina and/or MI with amlodipine initiation or dosage increase;
Monitor renal function and potassium in susceptible patients;
Disturbance of serum electrolyte balance (monitoring recommended), glucose tolerance and serum levels of cholesterol, triglycerides and uric acid;
Hx of angioedema with other drugs;
Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. This reaction is more common in patient with history of sulfonamide or penicillin allergy.
Thiazide diuretics have been reported to cause exacerbation or activation of SLE.
Not recommended in patients below 18 years of age
Pregnancy-Lactation
Interactions
- Simvastatin: Simvastatin doses should not exceed 20 mg daily when coadministered with amlodipine
- Antidiabetic drugs: Dosage adjustment of antidiabetic may be required
- Cholestyramine and colestipol: Reduced absorption of thiazides
- Lithium: Increased risk of lithium toxicity, monitor lithium levels.
- NSAIDs: Increased risk of renal impairment and loss of anti-hypertensive effect
- Other renin-angiotensin-aldosterone system (RAAS): Dual inhibition of the renin-angiotensin system resulting in increased risk of renal impairment, hypotension, and hyperkalemia
Adverse Effects
Side effects of Amlodipine + Valsartan + Hydrochlorothiazide :
Common adverse reactions include dizziness, peripheral edema, headache, dyspepsia, fatigue, muscle spasms, back pain, nausea, nasopharyngitis, asthenia, flushing. Less common may include orthostatic hypotension, tachycardia, vertigo, tinnitus, somnolence, syncope, noncardiac chest pain, chills, malaise, hypokalemia, diabetes mellitus, hyperlipidemia, hyponatremia, blood uric acid increased, blood creatine phosphokinase increased, weight decreased, erectile dysfunction, dyspnea, nasal congestion, cough